Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects
NCT ID: NCT01565252
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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As epidemiological research has shown negative effects of high egg consumption on increased all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate their effects on diseases risks, it is important to test the effect of eggs with different composition on markers associated with dyslipidemia, dysglycemia and inflammation.
The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.
Detailed Description
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First endpoint:
To assess the effect of high n-3 PUFA (Omega 3) egg, as compared to regular- high n-6 PUFA (Omega 6) Israeli egg, on glycemic levels after night fasting and post prandial of 2 egg breakfast test meal.
Secondary endpoint:
To compare the effect of high n-3 PUFA fortified egg versus high n-6 PUFA (Regular) egg on measures associated with CVD risks including: CRP, LDL oxidation, MDA, post prandial Flow mediated dilatation (FMD), liver enzymes, and blood lipids and lipoproteins, and further blood chemistry measures.
Third endpoint:
To assess the influence of n-3 Egg on erythrocytes fatty acid profile.
Study design: Prospective, Crossover, Compared Study Study population: 20 Healthy subjects
Study Methods:
Subjects will complete two study stages. In first stage study participants will get 3 weeks regimen including 2 Regular, Israeli (high n-6 Pufa) eggs/day.
In second stage after 3 weeks washout without eggs, study participants will get 3 weeks regimen with 2 high n-3Pufa eggs/day.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Stage 1
Dietary regimens:
Stage1 - all participants (N=20) in first stage will receive two regular (high n-6 PUFA) hard-boiled eggs/day at breakfast for a three weeks period for each participant.
No interventions assigned to this group
Stage 2
Stage 2 will be conduct after 3 weeks for wash-out with no eggs. All participants(N=20) in second stage will receive two high n-3 PUFA hard-boiled eggs/day at breakfast for a three weeks period for each participant.
eggs enriched Omega-3
In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
Interventions
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eggs enriched Omega-3
In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
Eligibility Criteria
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Inclusion Criteria
2. BMI 23-28
Exclusion Criteria
2. Known malignancy
3. Allergy to eggs or other materials use in the experiment
4. Substance abuse (including alcohol
18 Years
45 Years
MALE
Yes
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Pierre singer
Professor, MD
Principal Investigators
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Pierre Singer, Professor,MD
Role: PRINCIPAL_INVESTIGATOR
ICU dep't, Institute for Nutrition Research, Rabin MC
Niva Shapiro, Ph.D.,R.D.
Role: STUDY_CHAIR
Institute for Nutrition Research, Rabin MC
Milana Grinev, Study Coordinator
Role: STUDY_DIRECTOR
ICU dep't, Institute for Nutrition Research, Rabin MC
Locations
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Rabin Medical Center, Campus Beilinson
Petah Tikva, Petach Tikva, Israel
Countries
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Central Contacts
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Facility Contacts
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Pierre Singer, Professor,MD
Role: primary
Milana Grinev, Study Coordinator
Role: backup
Other Identifiers
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6445
Identifier Type: -
Identifier Source: org_study_id